Vigil 469905

GUDID 15099590221270

Vigil Lipid Control Level 1

Beckman Coulter, Inc.

Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control Multiple lipid analyte IVD, control

• Primary Device ID: 15099590221270
• NIH Device Record Key: 39858467-c8e1-4139-9abb-faaf14b537cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vigil
• Version Model Number: 469905
• Catalog Number: 469905
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590221270 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974452

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-24

On-Brand Devices [Vigil]

• 15099590232108: Vigil HbA1c Controls Levels 1 & 2
• 15099590227357: Vigil Serology Control Level 2
• 15099590227333: Vigil Serology Control Level 3
• 15099590227326: Vigil Serology Control Level C
• 15099590226916: Vigil Protein Control Level 1
• 15099590225421: Vigil TDM Control level 2
• 15099590225414: Vigil TDM Control level 3
• 15099590225315: Vigil TDM Control level 1
• 15099590223045: Vigil Protein Control Level 2
• 15099590222925: Vigil Lipid Control Level 2
• 15099590222918: Vigil Lipid Control Level 3
• 15099590222901: Vigil Lipid Control Level 4
• 15099590222611: Vigil Protein Control Level 3
• 15099590222604: Vigil Serology Control Level 1
• 15099590221270: Vigil Lipid Control Level 1